Behavior Problems in Early Childhood Clinical Trial
Official title:
An Ounce of Prevention is Worth a Pound of Cure: A Randomised Controlled Trial of Pedagogues Promoting Positive Parenting in a Home-visiting Program in At-risk Families
| Verified date | November 2023 |
| Source | University of Copenhagen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Supportive parenting is a strong predictor of positive outcomes for children, and harsh parenting is a risk factor for child development, especially for the child developing externalizing problems (overactive, oppositional, and aggressive behavior). Externalizing problems in preschoolers are predictive of a variety of problems in later childhood. Thus, parents are key targets for change in preventive programs with children at risk for developing externalizing problems. More than 95% of 2-6 year old Danish children spend an average of 7.5 hours, 5 days a week in a daycare setting, thus pedagogues are key frontline staff in the promotion of parental abilities and early childhood mental health. However, a recent Danish study shows that pedagogues experience a need for systematic skills and methods for intervening in families with a child at risk. Attachment-based programs enhancing parental sensitivity and parental sensitive discipline show promising results. This efficacy study examines the Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD)delivered by 22 VIPP-SD trained pedagogues at home-visits to 120 families with a child (1-6 years) identified to be at risk. Pedagogues are supervised by four VIPP municipality psychologists, thus promoting the cross-disciplinary collaboration. The results will point to future identification of families that may (and may not) profit from a pedagogue delivered VIPP-SD intervention, as well as to revise the intervention in order to maximizing its effect, i.e. point to changes to tailor intervention to the particular needs of different families in a Danish context.
| Status | Active, not recruiting |
| Enrollment | 130 |
| Est. completion date | December 2025 |
| Est. primary completion date | February 28, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 6 Years |
| Eligibility | Inclusion Criteria: - Child 2-6 year old - Parent must be more than 18 years old - Parent must speak and understand Danish - Family must live in the municipalities of Frederiksberg or Roskilde - and having no intentions of moving out of the municipality before after the intervention has ended - Parent can attend other treatment initiatives - Child must attend a daycare center in one of the two municipalities - Child must be at risk of developing externalizing behavior, i.e. showing signs of overactive, oppositional, and aggressive behavior. Exclusion criteria - Sexual or physical abuse by parent - Parental drug or alcohol abuse - Child diagnosis of autism - Child is not considered at risk of developing externalizing behavior problems, but may have other problems, such as delayed language or motordevelopment etc |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| University of Copenhagen | University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Parental attitudes toward sensitivity and sensitive discipline (ATSSD) | Questionnaire regarding parents' attitudes towards parenting (Bakermans-Kranenburg & Van IJzendoorn, 2003) | Through study completion, an average of 6 months | |
| Secondary | Parenting Daily Hassles (PDH) | Parenting Daily Hassles scale where parents are asked to rate 20 minor parenting stresses that often occur in families with small children (Crnic & Greenberg, 1990). | Through study completion, an average of 6 months | |
| Secondary | Parenting Stress | via self-report using Parenting Stress IndexTM, Fourth Edition Short Form (PSI-4-SF;Abidin, 1995) | Through study completion, an average of 6 months | |
| Secondary | Parental Mentalizing | self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, & Fonagy, 2017). | Through study completion, an average of 6 months | |
| Secondary | Family functioning | self-report using the McMaster Family Assessment Device (FAD), the six item version (de Haan et al., 2015) | Through study completion, an average of 6 months | |
| Secondary | Parental symptoms of anxiety | Anxiety symptoms will be assessed with GAD-7, which is a 7-item screening questionnaire for generalized anxiety disorder (Spitzer, Kroenke, Williams & Löwe, 2006). | Through study completion, an average of 6 months | |
| Secondary | Parental behavioral sensitivity and sensitive discipline | Parental sensitivity will be coded from video recordings of parent-child free play. Coding will be conducted using Coding Interactive Behavior (CIB) (Feldman, 1998).
Parental sensitive discipline will be coded from video recordings of a "don't touch task" and a "clean-up task". Coding procedure will be based on guidelines from Kuczynski et al., 1987 and Van der Mark et al., 2002. |
Through study completion, an average of 6 months | |
| Secondary | Child behavior problems | This is measured using the Strengths and Difficulties questionnaire (SDQ), which is completed by both parents and pedagogues (Goodman, 1997; Danish version by Niclasen et al., 2012). | Through study completion, an average of 6 months | |
| Secondary | Child socio-emotional development | Child socio-emotional development is assessed via parental report using the Ages & Stages Questionnaires®: Social-Emotional, Second Edition (ASQ®:SE-2) (Squires, Bricker, & Twombly, 2015). | Through study completion, an average of 6 months | |
| Secondary | Parental symptoms of depression | Depression symptoms will be assessed with PHQ-9, which is a 9-item questionnaire to monitor the severity of depression symptoms (Kroenke, Sptizer & Williams, 2001). | Through study completion, an average of 6 months |